This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation (NCT00248040), a randomized phase 2 study. The primary outcome is Creatinine Clearance (CrCl) in the Immediate Post-transplant Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00248040 |
| Phase | Phase 2 |
| Condition | Ischemia-Reperfusion Injury, Kidney Diseases |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dompé Farmaceutici S.p.A |
| Results posted | Yes |
2. Clinical Question
Population
High-risk patients undergoing kidney transplantation were the intended population. The primary endpoint description specifies an intention-to-treat population consisting of randomized patients who received any investigational product and a kidney transplant. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
Reparixin was studied using continuous and intermittent intravenous infusion schedules. The continuous schedule used an infusion pump and a dose of 2.772 mg/kg/h for 12 hours. The intermittent schedule used 2.244 mg/kg over a 30-minute period, followed by a 1.5-hour interval, with twelve doses over a total period of 22.5 hours.
Comparator
The comparator was placebo infusion: saline delivered using a volume and schedule matched to the continuous or intermittent infusion. The registry describes a randomized, double-blind, parallel-group comparison but does not report allocation details beyond those design features.
Primary question
The primary question concerned creatinine clearance in the immediate post-transplant period. It was assessed during the 1-3 and 10-12 hours post allograft reperfusion. The registry record does not report the resulting creatinine-clearance values or an estimate comparing either reparixin schedule with placebo.
The study was designed to explore reparixin’s safety and efficacy in preventing delayed graft function after kidney transplantation. Its biological rationale, as described in the registry, is that CXCL8 contributes to the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury, and reparixin is described as a specific CXCL8 inhibitor. That rationale motivates investigation; it is not evidence that the intervention changes clinical outcomes.
The broader outcome set included renal function measures, dialysis use and duration, graft-function categories, hospital stay, and mortality. These outcomes cover different aspects of early recovery. The registry record lists 14 outcome measures and 6 analyses, but it does not report a complete set of outcome estimates or explain how the outcomes were prioritized beyond naming creatinine clearance as the primary endpoint.
3. Trial Design
This was a Phase 2 randomized, double-blind, placebo-controlled, parallel-group pilot study. It enrolled 80 participants according to the registry record. The study compared continuous reparixin infusion and intermittent reparixin infusion with placebo infusion. The placebo was saline delivered using a schedule and volume matched to the infusion schedule. The record identifies the study as completed and lists the sponsor as Dompé Farmaceutici S.p.A.
The trial began in 2005-10, with primary completion in 2008-05. These dates describe the study timeline; they do not indicate when outcome data were collected for each participant. The registry record does not report the duration of follow-up for outcomes other than the primary endpoint’s early post-reperfusion measurement windows and the secondary measure concerning dialysis within 7 days post-transplant.
Randomization is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured baseline characteristics. Double masking can reduce the influence of treatment knowledge on participant care, outcome assessment, and reporting. These design features support a fair comparison, but their presence alone does not establish that the groups were balanced or that masking was maintained. The registry record does not report details about the randomization sequence, allocation concealment, or assessment of masking.
The continuous schedule was an intravenous dose of 2.772 mg/kg/h administered for 12 hours. The intermittent schedule was an intravenous dose of 2.244 mg/kg over a 30-minute period, followed by a 1.5-hour interval; twelve doses were administered over a total period of 22.5 hours. The record describes delivery into a high-flow central vein or through an arterio-venous fistula using an infusion pump. These regimen details distinguish the two active arms; they do not by themselves establish comparable exposure or equivalent treatment intensity.
Because the study is described as a pilot, its role is exploratory in the registry’s own framing. The registry record does not report a sample-size justification, a prespecified target difference for the primary endpoint, or a statistical analysis plan. It therefore does not support an assessment of whether the enrollment target was chosen to provide a particular precision or ability to detect a clinically important difference.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Six patients (2 in the reparixin continuous infusion group; 3 in the reparixin intermittent infusion group; 1 in the placebo intermittent infusion group) did not receive Investigational Product(s) or kidney transplants and hence they were excluded from both the Safety and ITT populations.
Overall Study
| Stage | Reparixin Continuous Infusion | Reparixin Intermittent Infusion | Placebo Continuous/Intermittent Infusion |
|---|---|---|---|
| STARTED | 25 | 23 | 26 |
| COMPLETED | 22 | 22 | 22 |
| NOT COMPLETED | 3 | 1 | 4 |
Reasons for not completing this period:
| Reason | Reparixin Continuous Infusion | Reparixin Intermittent Infusion | Placebo Continuous/Intermittent Infusion |
|---|---|---|---|
| transplantectomy | 2 | 1 | 3 |
| transplant cancelled post treat start | 1 | 0 | 0 |
| Death | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT population. The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Reparixin Continuous Infusion | Reparixin Intermittent Infusion | Placebo Continuous/Intermittent Infusion | Total |
|---|---|---|---|---|---|
| Participants analysed | 25 | 23 | 26 | 74 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 25 | 23 | 26 | 74 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 54.4 (SD 7.4) | 55.9 (SD 6.3) | 51.4 (SD 11.3) | 53.8 (SD 8.8) |
| Sex: Female, Male: Female | Participants | 18 | 13 | 19 | 50 |
| Sex: Female, Male: Male | Participants | 7 | 10 | 7 | 24 |
| Region of Enrollment: France | participants | 10 | 9 | 10 | 29 |
| Region of Enrollment: United States | participants | 2 | 2 | 4 | 8 |
| Region of Enrollment: Spain | participants | 7 | 5 | 4 | 16 |
| Region of Enrollment: Italy | participants | 6 | 7 | 8 | 21 |
6. Primary Endpoint
The registry lists the primary outcome as Creatinine Clearance (CrCl) in the Immediate Post-transplant Period, measured over 1-3 and 10-12 hours post allograft reperfusion.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL/min |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was mean creatinine clearance (CrCl), measured in mL/min during the immediate post-transplant period. Creatinine clearance is used as an indicator of kidney filtration: it reflects how much blood plasma is cleared of creatinine over a defined collection interval. In this study, it was intended to characterize early renal function after allograft reperfusion.
The registry describes two assessment windows: 1-3 and 10-12 hours post allograft reperfusion. At each timepoint, CrCl was determined from two 60 minute urine collections. Blood was withdrawn at the midpoint of each collection. An average was to be calculated from the two 60 minute values in each interval. The calculation uses urine creatinine concentration and urine volume, alongside serum creatinine concentration and collection time.
Using repeated short collection periods can provide an estimate of renal clearance at specified early intervals, rather than relying only on a later clinical event such as dialysis. However, a measured clearance value is an intermediate physiological measure. It should not be treated as interchangeable with graft-function categories, dialysis requirements, duration of hospital stay, or survival, which were listed as secondary outcomes.
The registry record states that the primary measure is a mean with standard deviation, but it does not report the observed means, standard deviations, group contrasts, confidence intervals, or tests for the endpoint. It also does not report how missing or incomplete urine collections were handled. Consequently, the endpoint’s definition can be described, but its observed results and comparative precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies early creatinine clearance as the primary endpoint and specifies two post-reperfusion assessment windows. It does not report the endpoint values for any group or the comparisons between the reparixin schedules and placebo. Therefore, the posted record does not permit a conclusion about the direction, magnitude, or precision of a difference in early creatinine clearance.
A mean summarizes the average measurement in a group, while the standard deviation describes variation among individual measurements around that mean. A group mean alone would not show how precisely the treatment contrast is estimated. A confidence interval, if reported, would show a range of values compatible with the data under the analysis assumptions; its width is relevant to precision. The registry record does not provide group means, standard deviations, or confidence intervals for the primary endpoint.
The primary endpoint was measured at two time windows, and the record lists multiple other outcomes covering renal tests, dialysis, graft-function categories, hospital stay, and mortality. Multiple outcomes and assessment times can create several opportunities to identify an apparently noteworthy result. Without a reported analysis plan, it is not possible to determine which comparisons were prespecified, whether any adjustment for multiplicity was planned, or how selective emphasis was avoided. The record lists 14 outcome measures and 6 analyses, but those counts alone do not reveal the number of tests or the analysis hierarchy.
Safety information is reported as counts of participants with serious adverse events and counts with other adverse events in each listed group. Serious adverse events were recorded for 12 of 25 in the continuous-infusion group, 5 of 23 in the intermittent-infusion group, and 9 of 26 in the placebo group. These figures describe event reporting in the registry; they are not adjusted comparisons and do not establish that the study treatment caused or prevented events. The record does not report statistical comparisons for these safety counts.
The registry also lists one death in the placebo group and none in either reparixin group. A death count by treatment group, without details about timing, cause, follow-up, or analysis, cannot establish a treatment effect on mortality. The record does not report those details in the information available for this analysis.
Thus, the main interpretive constraint is the absence of reported comparative efficacy results. The registry supports a description of the design, endpoint, and some safety counts, but not an estimate of whether either schedule differed from placebo. Any planning illustrations based on the observed effect should be read as hypothetical sample-size calculations, not as observed power or proof of a treatment effect.
9. Statistical Methods Explained
The statistical details that can be interpreted from the registry are limited. It identifies the endpoint as a continuous measure summarized by a mean and standard deviation, names the primary population, lists outcome measures and analyses, and describes a planning illustration based on the observed effect. It does not report the numerical primary outcome results or a complete statistical analysis plan. The concepts below explain how such methods are generally read without implying that unreported procedures were used in this study.
What does the mean describe?
A mean is the arithmetic average of the observations included in an analysis. For creatinine clearance, a group mean would describe the average measured clearance among the participants contributing values at a specified assessment window. It does not show the spread of individual observations or whether most participants had values close to the average. That is why the registry’s identification of standard deviation as the dispersion measure is relevant: standard deviation describes variability among the analyzed values, not uncertainty in the group mean itself.
The standard deviation should not be confused with a standard error or a confidence interval. A confidence interval concerns uncertainty about an estimate, such as a group mean or a between-group contrast. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. No confidence intervals or standard errors for the primary endpoint are reported in the registry record, so the precision of any treatment contrast cannot be assessed.
Why does the endpoint have separate time windows?
Creatinine clearance was assessed at 1-3 and 10-12 hours post allograft reperfusion, with two 60 minute urine collections contributing to an average at each interval. The windows represent distinct early measurements, not necessarily a single repeated-measures outcome. To interpret a contrast, readers would need to know whether each time window was analyzed separately, whether values were combined, and whether change over time was modeled. The registry record does not report those analysis details or the results for either window.
Repeated measurements on the same participant are generally correlated: one person’s readings may be more similar to each other than readings from different people. General statistical methods account for that dependence when estimating changes or treatment differences over time. The record does not identify a repeated-measures model, covariance structure, or any other method for handling within-participant correlation. No such method should be assumed.
How should a treatment contrast be read?
A treatment contrast compares an outcome between groups. For a continuous endpoint, it may be expressed as a difference in means, with a confidence interval and a test of a null hypothesis. The contrast’s direction depends on the order in which groups are subtracted, so the analysis should state that convention. The registry record does not report a contrast, its uncertainty, or a p-value for creatinine clearance. It is therefore not possible to describe the estimated size or direction of a primary endpoint effect.
A p-value, when reported, measures how unusual the observed data or more extreme data would be under a specified null model. It does not measure the probability that the null hypothesis is true, the probability that the result occurred by chance, or the size and clinical importance of an effect. Statistical significance alone would not establish clinical importance. In this record, no primary endpoint p-value is reported.
Why can over-dispersion matter?
General explanation: over-dispersion occurs when the observed variation in data is greater than a statistical model expects. It is especially relevant for count outcomes when a simple model assumes a particular relationship between the mean and variance. If over-dispersion is ignored, standard errors can be too small and confidence intervals too narrow, making results appear more precise than they are. The primary endpoint is continuous rather than a count, and the registry does not specify a model for it. This general issue should not be read as evidence that over-dispersion was present or that a particular correction was needed in this trial.
What do planning sample sizes mean?
The registry describes sample-size calculations as planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For outcomes other than time-to-event measures, the stated quantities are participants per arm for 80% power or participants per arm for 90% power; time-to-event calculations are described in terms of the total number of events. The effect to detect is described as a stated fraction of the observed effect.
Such figures are hypothetical planning aids. They answer how many participants or events a future study might require under the listed assumptions, not how much power this completed trial had. They are not observed power. The registry record does not report the numerical planning results in the information available for this analysis, so no sample-size value or effect fraction can be interpreted. In general, planning estimates depend on assumptions about the outcome’s variability, the target effect, allocation, significance level, and analysis. Changes in those assumptions change the implied sample size.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 14 outcome measures and 6 analyses. The listed outcomes include renal function tests, dialysis-related measures, graft-function categories, hospital stay, and mortality. The primary outcome itself has more than one assessment window. When studies examine multiple outcomes, timepoints, or group comparisons, the chance of at least one apparently unusual result can increase. Statistical plans may address this through a hierarchy of outcomes, adjustment methods, or clear separation of confirmatory and exploratory analyses. The registry record does not report whether any such approach was planned or used.
The primary endpoint population is described as the ITT population, defined as all randomized patients who received any investigational product and a kidney transplant. This definition is narrower than a strict intention-to-treat population that includes every randomized participant regardless of treatment receipt or transplant receipt. The registry record does not report how many randomized participants were excluded from this defined population, or whether other analysis populations were used for efficacy or safety.
The registry record does not report the amount or pattern of missing primary endpoint data, reasons for missingness, or methods for handling missing observations. It also does not report whether the analysis used imputation, complete cases, or another approach. Missingness can affect interpretation if the availability of measurements is related to health status or treatment assignment; this is a general concern, not a claim that such a pattern occurred in this trial.
The record does not report a statistical analysis plan, multiplicity adjustment, interim analysis procedures, or a sample-size justification. Their absence from the registry record means these methods cannot be evaluated; it does not establish that they were not conducted. Without the analysis plan and comparative results, readers cannot determine the prespecified status of particular analyses or assess selective reporting.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Reparixin Continuous Infusion | 12 | 25 | 48.0% |
| Reparixin Intermittent Infusion | 5 | 23 | 21.7% |
| Placebo Continuous/Intermittent Infusion | 9 | 26 | 34.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Reparixin Continuous Infusion | 0 of 25 |
| Reparixin Intermittent Infusion | 0 of 23 |
| Placebo Continuous/Intermittent Infusion | 1 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Reparixin Continuous Infusion | 24 of 25 |
| Reparixin Intermittent Infusion | 23 of 23 |
| Placebo Continuous/Intermittent Infusion | 25 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Reparixin Continuous Infusion | Reparixin Intermittent Infusion | Placebo Continuous/Intermittent Infusion |
|---|---|---|---|---|
| RENAL VEIN THROMBOSIS | Renal and urinary disorders | 1 of 25 | 0 of 23 | 3 of 26 |
| RENAL TUBULAR NECROSIS | Renal and urinary disorders | 2 of 25 | 0 of 23 | 1 of 26 |
| URETERIC FISTULA | Renal and urinary disorders | 1 of 25 | 1 of 23 | 1 of 26 |
| KIDNEY TRANSPLANT REJECTION | Immune system disorders | 0 of 25 | 1 of 23 | 1 of 26 |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | 2 of 25 | 0 of 23 | 0 of 26 |
| RENAL ARTERY THROMBOSIS | Renal and urinary disorders | 1 of 25 | 0 of 23 | 1 of 26 |
| HYPOTENSION | Vascular disorders | 2 of 25 | 0 of 23 | 0 of 26 |
| RETROPERITONEAL HAEMORRHAGE | Vascular disorders | 2 of 25 | 0 of 23 | 0 of 26 |
| Ileus | Gastrointestinal disorders | 0 of 25 | 1 of 23 | 0 of 26 |
| HYPERSENSITIVITY | Immune system disorders | 0 of 25 | 0 of 23 | 1 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Reparixin Continuous Infusion | Reparixin Intermittent Infusion | Placebo Continuous/Intermittent Infusion |
|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 6 of 25 | 10 of 23 | 12 of 26 |
| CONSTIPATION | Gastrointestinal disorders | 8 of 25 | 5 of 23 | 6 of 26 |
| RENAL TUBULAR NECROSIS | Renal and urinary disorders | 5 of 25 | 7 of 23 | 7 of 26 |
| HYPOTENSION | Vascular disorders | 6 of 25 | 5 of 23 | 3 of 26 |
| DIABETES MELLITUS | Metabolism and nutrition disorders | 6 of 25 | 3 of 23 | 4 of 26 |
| HYPOKALAEMIA | Metabolism and nutrition disorders | 4 of 25 | 6 of 23 | 3 of 26 |
| URINARY TRACT INFECTION | Infections and infestations | 4 of 25 | 5 of 23 | 2 of 26 |
| ACIDOSIS | Metabolism and nutrition disorders | 4 of 25 | 2 of 23 | 5 of 26 |
| VOMITING | Gastrointestinal disorders | 5 of 25 | 1 of 23 | 4 of 26 |
| HYPERKALAEMIA | Metabolism and nutrition disorders | 2 of 25 | 2 of 23 | 4 of 26 |
Serious events with the highest arm-level rate: renal vein thrombosis (11.5%), metabolic acidosis (8.0%), renal tubular necrosis (8.0%), hypotension (8.0%), retroperitoneal haemorrhage (8.0%).
The registry reports serious adverse event counts by treatment group. Serious events affected 12 of 25 participants in the reparixin continuous-infusion group, 5 of 23 in the reparixin intermittent-infusion group, and 9 of 26 in the placebo group. These are descriptive counts. They do not show whether events were judged related to treatment, how long participants were observed for safety, or whether the groups differed statistically.
The registry also lists participants affected by other adverse events: 24 of 25 in the continuous-infusion group, 23 of 23 in the intermittent-infusion group, and 25 of 26 in the placebo group. The record does not provide event-level detail for these counts in the information available for this analysis. Counts of participants affected are not the same as counts of individual events, since a participant may experience more than one event.
The listed serious-event terms include RENAL VEIN THROMBOSIS at 11.5%; METABOLIC ACIDOSIS, RENAL TUBULAR NECROSIS, HYPOTENSION, and RETROPERITONEAL HAEMORRHAGE at 8.0% each; and Ileus at 4.3%. The denominator and precise calculation basis for these listed percentages are not reported in the registry record. They should therefore be read as the record’s reported values, not recalculated or directly compared with participant counts without additional information.
The registry records no deaths in either reparixin group and one death in the placebo group. The available information does not specify cause, timing, or attribution. These figures cannot establish a causal safety difference between treatments.
12. What the Result Does, and Does Not, Mean
This record establishes that a randomized, double-blind, placebo-controlled pilot study evaluated two reparixin infusion schedules after kidney transplantation. It documents an early renal-function endpoint, a range of secondary outcomes, and selected adverse-event counts. Those details describe what the study set out to assess and some of the safety information entered in the registry.
It does not establish whether reparixin changed creatinine clearance, delayed graft function, dialysis use, hospital stay, or mortality. The registry record does not report comparative primary endpoint estimates, confidence intervals, or tests. Without those results, the direction and size of any difference are unknown, as is the precision with which it was estimated. Absence of a reported result is not evidence that groups were the same.
The safety counts are also not causal evidence. Differences in recorded counts may reflect treatment, underlying differences between groups, chance, duration of observation, or reporting and classification practices. The registry information does not provide enough detail to distinguish among these possibilities. In particular, the death count does not indicate why or when the death occurred or whether it was considered treatment-related.
The study’s pilot designation and Phase 2 status indicate an exploratory setting in the registry description, but they do not reveal the study’s statistical power or intended effect size. A planning calculation based on an observed effect is not observed power and cannot substitute for a reported estimate with uncertainty. The record does not include a sample-size justification, so the enrollment target cannot be interpreted as having been designed to detect a particular difference.
Accordingly, the most defensible reading is limited: the registry describes the design and endpoint and reports selected safety counts, while the primary comparative results are not reported in the registry record. No conclusion about efficacy or treatment-related safety differences follows from the available information alone.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a well-defined research question and a fully interpretable result. The registry specifies randomization, double masking, a placebo comparator, two active dosing schedules, and an early continuous primary endpoint. Those features help readers understand the intended comparison. Yet an endpoint definition cannot replace an outcome estimate: without group values and a contrast with uncertainty, the central statistical question remains unanswered by the registry record.
The study also illustrates the importance of matching an endpoint to the clinical process under study. Early creatinine clearance is a measure of renal function soon after reperfusion, whereas delayed graft function, dialysis, hospital stay, and mortality represent different outcomes. Measures can be related without being interchangeable. Interpreting a change in one as proof of a change in another would require evidence not reported in the registry record.
Two infusion schedules raise a further design and analysis issue. A study can compare each active schedule with placebo, compare the schedules with each other, or prioritize a particular contrast. Those questions are not equivalent, and multiple comparisons can affect interpretation. The registry identifies the arms but does not report the analysis hierarchy, prespecified contrasts, or multiplicity approach. That missing context limits what can be inferred from the list of outcomes and analyses.
Finally, the safety summary shows why event counts need context. Group denominators are reported, but the registry does not report the attribution, timing, or statistical comparisons necessary to interpret differences causally. A transparent statistical account would connect outcome definitions, analysis populations, missing data, prespecified comparisons, effect estimates, and uncertainty. Those elements are not all available in this registry record, making restraint in interpretation essential.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpretation is that the registry record does not report the primary creatinine-clearance results. No group means, standard deviations, between-group estimates, confidence intervals, or tests are available in the record. The central comparison of the two reparixin schedules with placebo therefore cannot be assessed for direction, magnitude, or precision.
The endpoint involves measurements in two early post-reperfusion windows and averages from urine collections. The record does not report completeness of collections, missing measurements, handling of missing values, or whether the two windows were analyzed separately or jointly. These details matter because the analysis approach determines which observations contribute to an estimate and how repeated measurements are treated.
The population definition says that the ITT population consisted of randomized patients who received any investigational product and a kidney transplant. This qualification leaves the status of randomized participants who did not meet those conditions unclear. The record does not report the numbers analyzed in the primary population or any alternative population definitions.
The registry lists multiple outcomes and analyses, but does not report a statistical analysis plan, a hierarchy of outcomes, or multiplicity procedures. It also does not report a sample-size justification or the numerical assumptions behind any design rationale. These omissions prevent assessment of whether the study was intended to estimate a particular contrast with a planned degree of precision.
The safety summary lacks information about event timing, exposure duration, seriousness criteria, treatment attribution, and the denominator used for listed serious-event percentages. The record also does not supply detail on the death’s cause or timing. These limitations constrain comparisons and causal interpretation. They are limitations of the information reported in the registry record and should not be mistaken for evidence that the underlying study did not collect or analyze these data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation — NCT00248040.
- Registry record last updated 2024-01-10; status last verified 2020-09.
- Results first posted 2020-04-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00248040 is a completed Phase 2 randomized, double-blind, placebo-controlled, parallel-group pilot study of reparixin after kidney transplantation in high-risk patients. The registry lists enrollment of 80 and compares continuous and intermittent reparixin infusion with schedule-matched placebo. The primary endpoint is mean creatinine clearance in mL/min, measured at 1-3 and 10-12 hours post allograft reperfusion.
The registry lists 14 outcome measures and 6 analyses, including renal function, dialysis, graft-function categories, hospital stay, and mortality. It reports serious and other adverse-event counts by group and selected serious-event terms. However, primary creatinine-clearance results and comparative efficacy estimates are not reported in the registry record. Details of the analysis plan, multiplicity handling, missing data, and sample-size justification are also not reported in the registry record.